Malaria, Falciparum Clinical Trial
Official title:
Phase IIa Exploratory, Open Label, Single/Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and PK of OZ439 in Adult Patients With Acute, Uncomplicated P. Falciparum or Vivax Malaria Mono-infection
A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.
This exploratory Phase IIa study aims to investigate the preliminary efficacy in terms of
parasite reduction and clearance in malaria patients, and the tolerability of OZ439
administered as single dose regimen at 3 different doses in parallel cohorts of patients
with either acute uncomplicated Plasmodium falciparum or Plasmodium vivax malaria
mono-infection (10 patients per plasmodium species per dose level).
Treatment with OZ439 will be given as a single dose on Day 0, starting in the first cohort
at a dose of 800 mg. Established antimalarial therapy will be given at the latest at 36
hours post dosing.
The primary endpoint will be the derived parasite reduction rate (PRR) at 24 hours after
study drug administration.
A review of each individual study cohort (dose/species) will be conducted with the Principal
Investigator and the Sponsor and a decision will be reached on whether the dose for the next
cohort should increase or decrease (within 200mg-1600mg range). This decision will be based
on parasite reduction rate over the first 24 hours following administration of OZ439,
tolerability and exposure.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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